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Company Overview
Arcturus Therapeutics Holdings Inc. is a globally recognized RNA medicines and vaccines company, founded in 2013 and based in San Diego, California. The company is distinguished by its focus on the application of advanced RNA technologies to develop innovative therapeutic solutions, with a strong emphasis on addressing rare diseases and enhancing public health outcomes. Through its pioneering work in RNA therapeutics, particularly in the development of self-amplifying messenger RNA (sa-mRNA) vaccines, Arcturus has established itself as a critical player in the biopharmaceutical research and development arena.
Core Technologies and Platforms
At the heart of Arcturus Therapeutics is a suite of enabling technologies that underscore its scientific expertise and research capabilities. The company leverages its proprietary LUNAR® lipid-mediated delivery system and STARR® mRNA Technology to facilitate the efficient delivery of nucleic acid medicines. These platforms enable the creation of a versatile range of products, including:
- Self-amplifying mRNA (sa-mRNA) vaccines – designed to elicit robust and durable immune responses using lower doses compared to conventional mRNA vaccines.
- RNA therapeutic candidates – targeting rare diseases such as liver and respiratory conditions, including therapeutic interventions for disorders like ornithine transcarbamylase deficiency and cystic fibrosis.
- Nucleic acid medicines – encompassing a broad array of modalities including small interfering RNA, circular RNA, antisense RNA, and gene editing therapeutics.
Research and Development Focus
Arcturus is deeply committed to expansive research and innovation. It actively pursues advanced nucleic acid technologies supported by an extensive patent portfolio that spans multiple regions including the U.S., Europe, Japan, and China. This intellectual property foundation not only safeguards its innovative work but also reinforces its competitive stance within the industry. The company’s R&D framework is built on a robust pipeline of clinical and preclinical projects, reflecting years of accumulated expertise in drug discovery and development of novel therapeutic modalities.
Strategic Collaborations and Market Position
Understanding the multifaceted challenges of the biotechnology sector, Arcturus has maintained a disciplined approach towards strategic collaborations. Its partnerships with prominent global biotechnology firms have enhanced its capability to develop and commercialize novel mRNA vaccines and therapeutics. A notable collaboration includes its joint venture in Japan, through which it has successfully advanced the world's first approved sa-mRNA COVID-19 vaccine. By combining its technical expertise with the commercial and regulatory strengths of its partners, Arcturus is positioned well within an increasingly competitive market segment that values innovation, scientific rigor, and timely execution.
Competitive Landscape and Value Proposition
Arcturus operates within a highly competitive field of biotechnology and RNA-based therapeutics, competing with firms that also invest heavily in novel medical technologies. What sets Arcturus apart is its concentrated focus on rare diseases and its ability to harness advanced mRNA delivery systems that maximize the therapeutic potential of low-dose formulations. Its differentiated approach is underpinned by a deep understanding of molecular biology and nanotechnology, enabling the development of safe and efficacious treatments that can be rapidly adapted to meet evolving healthcare challenges.
Business Model and Revenue Generation
The company generates revenue primarily through licensing its proprietary RNA technologies, strategic collaborations, and co-development agreements with industry partners. By concentrating on breakthrough products in special niche markets such as rare diseases, Arcturus maintains a focused business model that emphasizes quality, innovation, and operational efficiency rather than high-volume sales. This model has allowed it to allocate significant resources towards further research and regulatory advancement, ensuring a continuous stream of innovation and value creation for its stakeholders.
Expertise, Authoritativeness, and Industry Engagement
Arcturus Therapeutics reflects deep industry expertise through its scientific publications, active participation in global regulatory discussions, and a management team with extensive experience in drug discovery and therapeutic development. The company remains actively engaged in academic and clinical dialogues, ensuring that its approaches to RNA therapeutic development remain at the cutting edge of biomedical science. Such engagement fosters trust and validates the company’s methodologies among peers, investors, and public health experts alike.
Summary
In summary, Arcturus Therapeutics Holdings Inc. represents a paradigm shift in the field of RNA medicines and nucleic acid therapeutics. Its integration of innovative technology platforms, commitment to scientific excellence, and strategic market positioning have collectively defined it as a compelling entity in the biotech landscape. The company’s robust portfolio of patented technologies and its collaborative approach to overcoming healthcare challenges underscore its lasting impact on the development of next-generation medicines.
Arcturus Therapeutics (ARCT) reported Q4 2024 financial results and pipeline updates. The company announced Phase 2 interim data for ARCT-032 (Cystic Fibrosis) and ARCT-810 (OTC deficiency) expected in Q2 2025. Q4 2024 revenues were $22.8M, down from $30.9M in Q4 2023, with a net loss of $30.0M ($1.11 per share).
Key highlights include European Commission approval for KOSTAIVE, the first approved sa-mRNA COVID-19 vaccine, and MHLW approval for commercial manufacturing in Japan. The company reported $293.9M in cash and equivalents as of December 31, 2024, with an expected runway until Q1 2027. KOSTAIVE generated approximately $28.0M in gross profit share, currently being credited against program costs.
Full-year 2024 results showed revenues of $152.3M (down from $166.8M in 2023) and a net loss of $80.9M ($3.00 per share). R&D expenses increased to $195.2M, primarily due to higher clinical trial costs for OTC, CF, COVID-19, and LUNAR-FLU programs.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in Leerink's Global Healthcare Conference 2025. The company will engage in a fireside chat session scheduled for Wednesday, March 12, 2025, at 10:40 a.m. Eastern Time in Miami. Interested parties can access the webcast through the Investor Relations/Events section of the Arcturus website.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company, announced it will release its Q4 and full-year 2024 financial results after market close on March 6, 2025. The company, which focuses on developing infectious disease vaccines and liver and respiratory rare diseases treatments, will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day.
Investors can access the earnings call through domestic (1-800-267-6316) or international (1-203-518-9783) dial-in numbers using the Conference ID: ARCTURUS. A webcast link will also be available.
CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.
KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.
CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.
KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.
The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.
Arcturus Therapeutics (Nasdaq: ARCT) has announced the appointment of Dr. Moncef Slaoui as Chair Designate. Dr. Slaoui, who has been serving on the Company's Board of Directors since June 2024, brings extensive experience in the pharmaceutical and biotechnology industry. The company, which focuses on commercial messenger RNA medicines for infectious disease vaccines and rare diseases affecting liver and respiratory systems, is entering what it describes as a transformative year with multiple key data readouts expected across its pipeline.
Meiji Seika Pharma has received approval to add domestic manufacturing sites in Japan for KOSTAIVE®, their self-amplifying mRNA COVID-19 vaccine. The approval enables integrated production within Japan, with ARCALIS's Minami-soma facilities and Meiji Seika Pharmatech added as manufacturing sites.
The technology transfer was managed by CSL Seqirus, the global licensor of KOSTAIVE®. The domestic production includes manufacturing of active pharmaceutical ingredients at ARCALIS's facilities and formulation at Meiji Seika Pharmatech, allowing for commercial distribution in Japan. This development involves Arcturus Therapeutics' LUNAR® lipid nanoparticle formulation processes and STARR® sa-mRNA drug substance manufacturing technologies.
Arcturus Therapeutics (ARCT) has initiated a Phase 1 study of ARCT-2304 (LUNAR-H5N1), a self-amplifying mRNA vaccine candidate for pandemic H5N1 influenza prevention. The trial, fully funded by BARDA, began in December 2024 and aims to enroll approximately 200 healthy adults across multiple U.S. sites.
The randomized placebo-controlled study will evaluate three dose levels and two vaccination schedules, focusing on safety and immune responses measured through various assays. The vaccine utilizes LUNAR® delivery and STARR® mRNA technologies, which have previously demonstrated robust immune responses at low doses and extended neutralizing antibody persistence compared to conventional mRNA vaccines.
LUNAR-H5N1 becomes the third STARR® mRNA vaccine to enter clinical trials, with interim Phase 1 data expected in H2 2025. The technology's safety profile has been established through previous trials involving over 20,000 participants.
Arcturus Therapeutics (ARCT) has initiated Phase 2 dosing for both its Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) deficiency therapeutic programs in December 2024. In the CF study (NCT06747858), participants will receive daily treatments of ARCT-032 over 28 days. For the OTC deficiency program, the first participant received 0.5 mg/kg of ARCT-810 in the United States, with participants scheduled to receive five intravenous infusions over two months.
The company previously completed a placebo-controlled European study for OTC deficiency (N = 8; 0.3 mg/kg) and expanded the Phase 2 clinical program of ARCT-810 into the US with an open-label multiple-dose study (NCT06488313). Interim data for both mRNA therapeutic programs is expected in the first half of 2025.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Joseph Payne, President & CEO, will deliver a presentation at the conference in San Francisco on Wednesday, January 15, 2025, at 9:45 a.m. Pacific Time. Investors and interested parties can access the presentation webcast and replay through the company's investor relations website at ir.arcturusrx.com/investor-calendar.
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